dutasteride in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy

Conditions: Prostate Cancer

Summary: rationale: dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase ii trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.

objectives: primary * evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride. * evaluate the toxicity of dutasteride in these patients. secondary * evaluate the serum prostate-specific antigen (psa) level and objective radiographic response rate in patients treated with dutasteride. * determine the survival of patients treated with dutasteride. * determine the quality of life of patients treated with dutasteride. outline: patients receive oral dutasteride once daily until disease progression or unacceptable toxicity. quality of life is assessed at baseline and then every 3 months thereafter. after completion of study treatment, patients are followed periodically. projected accrual: a total of 27 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of prostate cancer * asymptomatic progressive disease despite androgen-deprivation therapy * progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (lhrh) analogue with or without antiandrogen and after antiandrogen withdrawal * concurrent lhrh monotherapy (i.e., lhrh analogs, such as leuprolide acetate or goserelin) required in patients who did not undergo prior bilateral orchiectomy to assure testicular androgen suppression * recurrent disease, as indicated by at least 1 of the following: * prostate-specific antigen (psa) at baseline ≥ 2.0 ng/ml * biopsy-confirmed local recurrence * increase in size of measurable lesions on radiographic study * new lesion on a nuclear bone scan * two successive increases in serum psa measured at least 1 week apart patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 12 weeks * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9.0 g/dl * bilirubin ≤ 2.0 mg/dl * sgot ≤ 4 times upper limit of normal * creatinine ≤ 2.0 mg/dl * fertile patients must use effective contraception during and for 3 months after completion of study therapy prior concurrent therapy: * see disease characteristics * at least 28 days since prior radiotherapy and recovered * at least 28 days since prior flutamide or at least 42 days since prior bicalutamide or nilutamide * patients who have previously progressed despite antiandrogen withdrawal and who have started antiandrogens without reduction of serum psa are eligible without requiring a 28- or 42-day washout interval after antiandrogen withdrawal * no other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or lhrh analogues only) or antiandrogens * surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies * no other concurrent anticancer therapy * no concurrent use of any of the following: * finasteride * other investigational 5α-reductase inhibitors * anabolic steroids * alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin) * drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents) * products containing selenium ≥ 75 mcg or vitamin e ≥ 100 iu * saw palmetto * eg6761 * no concurrent radiotherapy, including palliative radiotherapy for pain control

Keywords: recurrent prostate cancer